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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients
American Journal of Transplantation, Volume 5, No. 10, Year 2005
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Description
Everolimus 1.5 or 3 mg/day was compared with mycophenolate mofetil (MMF) 2 g/day in a randomized, multicenter 36-month trial in de novo renal allograft recipients (n = 588) receiving cyclosporine microemulsion (CsA) and corticosteroids. The study was double-blind until all patients had completed 12 months, then open-label. By 36 months, graft loss occurred in 7.2, 16.7 and 10.7% of patients in the everolimus 1.5, 3 mg/day, and MMF groups, respectively (p = 0.0048 for everolimus 1.5 mg/day vs. 3 mg/day); efficacy failure (biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up) occurred in 33.0, 38.9 and 37.2% of patients (p = 0.455 overall), respectively. Mortality and incidence of BPAR were comparable in all groups. Creatinine values were higher in everolimus groups, requiring a protocol amendment that recommended lower CsA exposure. Diarrhea, lymphocele, peripheral edema and hyperlipidemia were more common among everolimus-treated patients, whereas viral infections, particularly cytomegalovirus infection, increased in the MMF group. Overall safety and tolerability were better with MMF and everolimus 1.5 mg/day than with everolimus 3 mg/day. In conclusion, at 36 months, an immunosuppressive regimen containing everolimus 1.5 mg/day had equivalent patient, and graft survival and rejection rates compared with MMF in de novo renal transplant recipients, whereas everolimus 3 mg/day had inferior graft survival. Renal dysfunction in everolimus cohorts necessitates close monitoring. Copyright © Blackwell Munksgaard 2005.
Authors & Co-Authors
Vítko, Štefan
Czech Republic, Prague
Institutu Klinické a Experimentální Medicíny
Margreiter, Raimund
Austria, Innsbruck
Department Operative Medizin, Innsbruck
Weimar, Willem W.
Netherlands, Rotterdam
Erasmus Mc
Dantal, Jacques
France, Nantes
Hôtel Dieu Chu de Nantes
Kuypers, Dirk
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Winkler, Michael
Germany, Hannover
Hannover Medical School
Øyen, Ole
Norway, Oslo
Rikshospitalet-radiumhospitalet hf
Viljoen, Hendrik G.
South Africa, Cape Town
Garden City Hospital
Filiptsev, Pavel
Russian Federation, Moscow
City Clinical Hospital No.
Sadek, Sami
United Kingdom, Portsmouth
Queen Alexandra Hospital
Li, Yulan
Switzerland, Basel
Novartis International ag
Cretin, Nathalie
Switzerland, Basel
Novartis International ag
Budde, Klemens
Germany, Berlin
Charité – Universitätsmedizin Berlin
Statistics
Citations: 217
Authors: 13
Affiliations: 12
Identifiers
Doi:
10.1111/j.1600-6143.2005.01063.x
ISSN:
16006135
e-ISSN:
16006143
Research Areas
Disability
Health System And Policy
Study Design
Cohort Study